[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Pages 61627-61628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30405]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Chlortetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Hoffmann-La Roche, Inc. The supplemental 
NADA provides for changing the withdrawal time to zero following 
certain uses of chlortetracycline (CTC) in Type C cattle feeds 
(including free-choice feeds).

EFFECTIVE DATE: November 19, 1997.
FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1638.

SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St., 
Nutley, NJ 07110-1199, filed supplemental NADA 48-761 that provides for 
decreasing the withdrawal times for all National Academy of Sciences/
National Research Council drug efficacy study implementation (NAS/NRC 
DESI) approved uses of CTC Type C medicated feeds (including free-
choice feeds) for beef and nonlactating dairy cattle and for control of 
anaplasmosis and other claims to a zero withdrawal time. The 
supplemental NADA is approved as of September 23, 1997, and the 
regulations are amended in Sec. 558.128(d)(1) and (d)(2) (21 CFR 
558.128(d)(1) and (d)(2)) to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    Also, in the revision of Sec. 558.128 published in the Federal 
Register of

[[Page 61628]]

July 9, 1996 (61 FR 35949), FDA provided for approval of five 
supplemental NADA's to reflect compliance with the results of the NAS/
NRC DESI review of the products and FDA's conclusions based on that 
study. In that document, FDA failed to reflect that Hoffmann-La Roche 
is the sponsor of the product codified in Sec. 558.128(d)(2) (see 53 FR 
31316, August 18, 1988). The sponsor was the subject of a change of 
sponsor from American Cyanamid published in the Federal Register of 
April 24, 1996 (61 FR 18081). At this time, the paragraph is amended to 
reflect the correct sponsor.
     In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of human food safety data and 
information submitted to support approval of this supplement may be 
seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec. 558.128  [Amended]

    2. Section 558.128 Chlortetracycline is amended in the table in 
paragraph (d)(1) in entry (xi) in the column ``Limitations'' by adding 
after the existing text the sentence ``For sponsor 000004 zero 
withdrawal time.'', in entry (xii) for indication 1., in the column 
``Limitations'' by adding after the phrase ``for sponsor 048573;'' the 
phrase ``zero withdrawal for sponsor 000004;'', in entry (xvii) for 
indication 1., in the column ``Limitations'' by adding after the 
existing text the sentence ``For sponsor 000004 zero withdrawal 
time.'', and in paragraph (d)(2) by adding after the number ``(2)'' the 
phrase ``For sponsor 000004:'' and removing the phrase ``discontinue 
use 4 days prior to slaughter''.

    Dated: November 3, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-30405 Filed 11-18-97; 8:45 am]
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